WHO-GMP Certified Commercial Pack · Product Code: AKP-062
Paradichlorobenzene 2%, Benzocaine 2.7%, Chlorbutol 5% & Turpentine Oil 15% Ear Drops
Formulation Overview: Complete ceruminolytic otic formulation softening hardened impacted earwax while benzocaine and chlorbutol provide gentle canal analgesia and antimicrobial preservation. Formulated with Paradichlorobenzene 2.0% + Benzocaine 2.7% + Chlorbutol 5.0% + Turpentine Oil 15.0% w/v (2% + 2.7% + 5% + 15% w/v) in Sterile Otic Ear Drops dosage form under Ophthalmic & Otic Care, manufactured to IP / BP / USP Compendial standards and supplied in 10 ml Amber Glass / LDPE Dropper Bottle with Carton with complete eCTD/ACTD regulatory dossiers, Zone IVb stability, and batch CoA for African NRAs (NAFDAC, PPB, SAHPRA, TMDA, FDA Ghana) and global tenders.
| Item Code (SKU) | AKP-062 |
|---|---|
| Therapeutic Sector | Ophthalmic & Otic Care |
| Dosage Form | Sterile Otic Ear Drops |
| Active Ingredient | Paradichlorobenzene 2.0% + Benzocaine 2.7% + Chlorbutol 5.0% + Turpentine Oil 15.0% w/v |
| Strength / Purity | 2% + 2.7% + 5% + 15% w/v |
| Clinical Indication | Impacted earwax (cerumen) softening and ear canal discomfort prior to syringing |
| Specification Standard | IP / BP / USP Compendial |
| Packaging Format | 10 ml Amber Glass / LDPE Dropper Bottle with Carton |
| Shelf Life | 24–36 Months |
| Storage Conditions | Store below 25°C; tightly closed; external otic use only (not for perforated tympanic membrane) |
| Minimum Order Quantity | 1000 Packs |
| Regulatory / Analytical Docs | Full eCTD / ACTD Modules 1–5 + Zone IVb Stability Available |
| African & Global NRA Readiness | NAFDAC (Nigeria), PPB (Kenya), SAHPRA (SA), TMDA (Tanzania), FDA Ghana, AIRP, ARP, EFDA |
| Stock Availability | In Stock · Immediate Commercial Dispatch |
| Supply Status | Commercial Export Ready |